BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1079 AIRCAL CALORIC STIMULATOR

    MDR report key: 11572180 · Received March 25, 2021

    Report

    Report Number
    9612197-2021-00005
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 17, 2021
    Manufacturer
    NATUS MEDICAL DENMARK
    Product Code
    KHH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 003 REF NATUS COMPLAINT#: (B)(4). CUSTOMER REPORTS THE DEVICE OVERHEATS AND IS UNABLE TO COOL THE MEDIUM TO THE DESIRED TEMPERATURE. DEVICE HAS BEEN RECEIVED FOR EVALUATION AND THE FOLLOWING WAS COMPLETED: REPAIR TASK DELIVERY HEAD DAMAGED AND REASSEMBLED THE WRONG WAY, REPLACED WITH ATO (SVI 2044-0026). SERRATED WASHER ADDED. SINTER SILENCER REPLACED. FUNCTION TESTED, CALIBRATED, FINAL TESTED AND HIGH VOLTAGE TESTED SUCCESSFULLY. REPAIRED DEVICE SHIPPED BACK TO CUSTOMER. CAPA AND COMPLAINT TRENDING REVIEW: THERE ARE NO CAPA'S RELATED TO THIS ISSUE. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE ) AND ANY COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW (B)(4). NO TREND FOR THIS DEVICE IDENTIFIED. RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT). THE CURRENT RISK FILE: (B)(4) REV 04 HAZARD ID 6.2 IDENTIFIES THIS ISSUE HARM - USER OR PATIENT COULD INJURE THEMSELVES. CAUSE- HIGH TEMPERATURE ON SURFACES OF ENCLOSURES THAT ARE LIKELY TO BE CONTACTED SUCH HANDLE OF THE OTOSCOPE. SEVERITY- CRITICAL (11). RISK LEVEL - MEDIUM (33). A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. A DEVICE HISTORY REVIEW OF (B)(4) REVIEWED. DEVICE IN SERVICE SINCE - INSTALLED: ON (B)(6) 2014 EXPECTED SERVICE LIFE- THE USEFUL LIFE EXPECTED FROM THE PRODUCT IS 5 YEARS AS STATED IN RISK FILE: (B)(4) REV 04. CLOSURE RATIONALE:COMPLAINT VERIFIED, BEING TRACKED AS A TREND.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(4). WAITING ON AFFECTED PRODUCT TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). AWAITING ON AFFECTED PRODUCT TO BE RETURNED FOR EVALUATION. CAPA AND COMPLAINT TRENDING REVIEW: THERE ARE NO CAPA'S RELATED TO THIS ISSUE. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE ) AND ANY COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOC-052150. NO TREND FOR THIS DEVICE IDENTIFIED RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT) THE CURRENT RISK FILE 7-38-02811 REV 04 HAZARD ID 6.2 IDENTIFIES THIS ISSUE HARM - USER OR PATIENT COULD INJURE THEMSELVES CAUSE- HIGH TEMPERATURE ON SURFACES OF ENCLOSURES THAT ARE LIKELY TO BE CONTACTED SUCH HANDLE OF THE OTOSCOPE SEVERITY- CRITICAL (11). RISK LEVEL - MEDIUM (33). A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. A DEVICE HISTORY REVIEW OF DOC-60-54-0155 REVIEWED. DEVICE IN SERVICE SINCE - INSTALLED: (B)(6) 2014.

    Description of Event or Problem · 0

    THE DEVICE OVERHEATS AND IS UNABLE TO COOL THE MEDIUM TO THE DESIRED TEMPERATURE DURING OPERATION. NO INJURY, NO PATIENT INVOLVEMENT. THE CUSTOMER STOPPED USING IT.

    Description of Event or Problem · 0

    THE DEVICE OVERHEATS AND IS UNABLE TO COOL THE MEDIUM TO THE DESIRED TEMPERATURE DURING OPERATION. NO INJURY, NO PATIENT INVOLVEMENT. THE CUSTOMER STOPPED USING IT.

    Description of Event or Problem · 0

    THE DEVICE OVERHEATS AND IS UNABLE TO COOL THE MEDIUM TO THE DESIRED TEMPERATURE DURING OPERATION. NO INJURY, NO PATIENT INVOLVEMENT. THE CUSTOMER STOPPED USING IT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THE PROCEDURE CARRIED OUT AT THE TIME WAS COOLING PROCEDURE BEFORE IRRIGATION. THE DEVICE SUDDENLY STOPPED WORKING PRECISELY. THE DEVICE IS NOT ABLE TO COOL THE TEMPERATURE TO 24°C. NO INJURY. NO PATIENT INVOLVEMENT. THE CUSTOMER STOPPED USING IT. ALL COMPONENTS OF THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE DEVICE OVERHEATS AND IS UNABLE TO COOL THE MEDIUM TO THE DESIRED TEMPERATURE DURING OPERATION. NO INJURY, NO PATIENT INVOLVEMENT. THE CUSTOMER STOPPED USING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469815 1079 AIRCAL CALORIC STIMULATOR 1079 AIRCAL CALORIC STIMULATOR KHH NATUS MEDICAL DENMARK 8-04-13300

    Patients

    Seq Age Sex Outcome Treatment
    1